A Study of Carmustine With and Without Ethanol in Subjects With Lymphoma
Purpose
A phase 2 multicenter study of VI-0609 vs BiCNU in the BEAM high-intensity conditioning regimen for AHCT in subjects with lymphomas.
Conditions
- Lymphoma
- Non-Hodgkin Lymphoma
- Hodgkin Lymphoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Male and female adults ≥ 18 years of age with a life expectancy ≥ 6 months; - Karnofsky performance status ≥ 70%; - Histologically confirmed Hodgkin lymphoma or Non-Hodgkin lymphoma; - Candidate for AHCT consolidation therapy as assessed by their treating physician; - Achieved a complete or partial response; - Completed collection of at least 2.0 x 10^6 CD34 cells/kg of autologous hematopoietic progenitor cells (HPCs) by apheresis; - Recovery from non-hematologic toxicities of salvage cytoreductive chemotherapy to ≤ grade 2; - Clinical laboratory and organ function criteria meeting study ranges/limits LVEF ≥ 50%; FEV1 > 65% of predicted measurement, DLCO ≥ 50% of predicted; - Seronegative for HIV Ag/Ab combo, HCV, active HBV, and syphilis
Exclusion Criteria
- Prior high-dose chemotherapy with autologous stem cell transplant, or prior allogeneic transplantation; - Significant prior external beam dose-limiting radiation to a critical organ based on review of the prior radiation treatment records; - Use of any other investigational medication or device, or concurrent biological, chemotherapy, or radiation therapy; - Myelodysplasia or any active malignancy other than HL or NHL, or < 5 years remission from any other prior malignancy; - Any cytogenetic abnormality in the bone marrow that is known to be associated with or predictive of myelodysplasia; - Persistent marrow involvement (>10%) with HL or NHL after salvage cytoreductive therapy and before stem cell mobilization; - Not having sufficient bone marrow harvest to reach adequate cell dose for transplant; - Active hepatitis B or C viral infection or HBsAg positive; - Positive HIV antibody;
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental VI-0609 |
VI-0609 (Carmustine with Propylene Glycol) |
|
|
Active Comparator BiCNU |
BiCNU (Carmustine with Ethanol) |
|
Recruiting Locations
City of Hope National Medical Center
Duarte, California 91010
Duarte, California 91010
More Details
- NCT ID
- NCT06915246
- Status
- Recruiting
- Sponsor
- VIVUS LLC